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Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

CompletedNA

Sponsor: The Cleveland Clinic

Conditions: Liver Transplantation

Interventions: Thymoglobulin 3mg total, Thymoglobulin 4.5mg total, Mycophenolate mofetil, tacrolimus 3-8, tacrolimus 8-12

Countries: United States

This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients undergoing deceased donor solitary liver transplantation
* Adults aged 18-70 at time of transplantation
* Hepatocellular carcinoma as indication for OLT within the Milan Criteria
* Hepatitis C positive or negative patients
* Willingness to comply with study procedures
* Able to sign informed consent

Exclusion Criteria:

* Prior kidney transplantation
* Congenital or iatrogenic absence of one kidney
* Subjects on renal replacement therapy at the time of OLT
* MELD score \> 28
* HIV positive patient
* Patient with current severe systemic infection
* History of bacterial peritonitis within 30 days prior to OLT
* Active infection or recent infection within 30 days prior to OLT
* Use of calcineurin inhibitor continuously for more than 90 days within the past 6 months
* History of hypersensitivity to thymoglobulin, rabbits, tacrolimus or iohexol
* Women of childbearing age who are unwilling to use effective contraceptive methods during the duration of the study

Locations (1)

Cleveland, Ohio, United States